MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-12-10 for ELECSYS FREE PSA IMMUNOASSAY 03289788160 manufactured by Roche Diagnostics.
[130346573]
Na.
Patient Sequence No: 1, Text Type: N, H10
[130346574]
The customer complained of questionable elecsys free psa immunoassay and elecsys total psa immunoassay results for 1 patient sample tested on a cobas e 411 immunoassay analyzer serial number (b)(4). The customer questioned a possible interference in the patient sample. This medwatch will cover the free psa. Please refer to the medwatch with patient identifier (b)(6) for data on the total psa data. The initial total psa result was 0. 063 ng/ml with a repeat result of 0. 063 ng/ml. The initial free psa result was 0. 151 ng/ml with repeat results of 0. 154 ng/ml and 0. 156 ng/ml. No erroneous results were reported outside of the laboratory. There was no adverse event. The field service engineer (fse) performed an instrument performance check that was acceptable. The instrument was performing within specifications. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-04727 |
| MDR Report Key | 8147420 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-12-10 |
| Date of Report | 2018-12-26 |
| Date of Event | 2018-11-16 |
| Date Mfgr Received | 2018-11-20 |
| Date Added to Maude | 2018-12-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECSYS FREE PSA IMMUNOASSAY |
| Generic Name | TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA |
| Product Code | MTG |
| Date Received | 2018-12-10 |
| Model Number | NA |
| Catalog Number | 03289788160 |
| Lot Number | 00330824 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-10 |